VITROS 3600 Immunodiagnostic System Catalog Nos — Class II medical device recall Z-1229-2024
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2024-03-13, distributed nationwide. A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configu
| Recall number | Z-1229-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2024-01-26 |
| Classified | 2024-03-01 |
| Reported by FDA | 2024-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CL, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PT, RU, SE, SG |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10758750002979, 10758750007103 |
| Serial numbers | J36000109, J36000148, J36000292, J36000340, J36000348, J36000406, J36000407, J36000427, J36000446, J36000489, J36000511, J36000517, J36000580, J36000612, J36000626, J36000688, J36000753, J36000861, J36000877, J36000920, J36000923, J36000929, J36000933, J36000941, J36000942 and 50 more |
| Model numbers | 6802783 |
Product
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Reason for recall
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1229-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.